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NCT01465659 · ClinicalTrials.gov registry record · Phase 1
Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01465659: Completed Phase 1 study, sponsored by Northwestern University.
NCT01465659 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01465659, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how well they work in treating patients with advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective treatment for patients with PNET.
Primary Outcome
MTD and recommended phase II dose (RP2D) determination for the combination of temozolomide in combination with 400mg pazopanib in patients with advanced PNET will be achieved using a standard "3+3" dose escalation/de-escalation design. After each 3 patients are enrolled into the study, further enrollment will be temporarily suspended until safety has been reviewed for the first 28 days of treatment to determine if dose limiting toxicities have been experienced by patients and if a further 3 pati
Interventions
- DRUG temozolomide
- DRUG pazopanib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-12-12 |
| Est. Completion | 2021-01-27 |
| Phase | Phase 1 |
What the finished NCT01465659 record still lists
NCT01465659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which temozolomide is the first listed.
NCT01465659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01465659 about?
NCT01465659 is a clinical study titled "Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery". This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how well they work in treating patients with advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs used in chemotherapy, such as...
What is the current status of trial NCT01465659?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2011-12-12. Estimated completion is 2021-01-27.
What interventions are being tested in trial NCT01465659?
The interventions under investigation include: temozolomide (DRUG), pazopanib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01465659?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01465659's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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